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Law360 (November 13, 2020, 9:32 PM EST) -- The U.S. Food and Drug Administration said Friday that it's looking into whether an American unit of a China-owned diagnostics company should get an exclusive license to use a government-owned patent for technology to detect SARS-CoV-2, the virus that causes COVID-19.
Ithaca, New York-based Advion Inc., a leading developer of diagnostic systems that's owned by Beijing-based Bohui Innovation Biotechnology Co., is being considered for the license to U.S. Patent 8,704,169 B2, the agency said in a Federal Register notice. The patent covers technology and methods for a mass spectrometer to detect viruses and bacteria.
"The prospective exclusive license territory may be worldwide and in fields of use that may be limited to manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of SARS, SARS-CoV-2 and other viruses," the agency said in the notice.
When it acquired Advion in 2015, Bohui said it made the purchase to expand its global footprint in North America. Bohui's former CEO Lu Xinqun said in a 2015 statement that the company "intends to fully fund Advion's [research and development] projects to strengthen its market position, and to promote Advion's products in the Chinese market."
"Advion's strong presence in North America and the EU also allow for Bohui to gain a more balanced global footprint," Xinqun said.
Lauren K. Roth, the FDA's acting principal associate commissioner for policy, who issued the notice, asked for the public to express any concerns about the exclusive license. That license "may be granted" if no concerns are raised within 15 days of the notice, she said.
Ethics and economics debates about access to intellectual property related to COVID-19 have swirled in recent months since the coronavirus pandemic was first identified in Wuhan, China, in December 2019. The virus has since made its way around the world, infecting over 53 million people and killing over 1.3 million, according to Johns Hopkins University.
The debate has recently focused on global access to patents for vaccines and treatments related to the coronavirus, especially as the private sector has stepped up to make its intellectual property temporarily available during the pandemic. Moderna Therapeutics said last month that it won't enforce seven patents related to its COVID-19 vaccine during the pandemic.
Other companies have been inching toward expanding access to vaccines developed during the pandemic. AstraZeneca announced in August that it would allow all European Union member states to access its vaccine "in an equitable manner at no profit."
There's also been a push by consumer advocates to convince the federal government to take pharmaceutical giants' patents for COVID-19 treatments if government-funded research played a role in a patented invention.
--Editing by Breda Lund.
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